Dentures Biofilm and Artificial Biofilm Substitute

NCT04247438 | Completed

• 2 other identifiers: TUDKW20200115427547277
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The biofilm on oral surfaces can lead to oral diseases. The correlation between oral biofilm and diseases and general health is well known. Therefore, cleaning of teeth or dentures from biofilm is essential for the maintenance of oral and general health. Currently, the society is ageing, the number of elderly as well as home and institutionalized care patients is increasing. In particular, these suffer from higher tooth loss, wear removable dentures and have problems with independent oral and denture hygiene. Therefore, support from well-trained nursing staff or family members is important. The use of suitable artificial biofilm substitutes may be helpful, in order to efficiently and easily perform oral and denture hygiene education, as well as to carry out laboratory tests of oral and denture hygiene products. The absence of such appropriate substitutes for denture biofilm requires innovations in this field. The aim of this pilot study is to verify the feasibility of the study protocol, design and methods. Additionally, an innovative artificial biofilm substitute based on polysaccharides will be further developed. This pilot study includes five study parts. Two in vivo examinations and three in vitro tests. This pilot study creates the basis for further main studies and implements the development of validated artificial biofilm substitutes.

Conditions

Biofilm

Keywords

dental biofilm; dental plaque; polysaccharides; chitosan; methylcellulose; denture biofilm; denture plaque; biofilm model

Outcome Measures

Primary Outcomes (2)

• dentures brushing cycles 12 h in vivo

  Capturing the data for the number of brushing cycles needed to remove artificial biofilm from dentures worn by participants for 12h.

  2 days

• brushing cycles in vitro

  Capturing the data for the number of brushing cycles needed to remove artificial biofilm from dentures or samples.

  4 months

Secondary Outcomes (4)

• percentage of plaque (POP)

  3 - 12 weeks

• dentures brushing cycles 36 h in vivo

  4 days

• samples brushing cycles 12 h in vivo

  2 days

• samples brushing cycles 36 h in vivo

  4 days

Study Arms (1)

Biofilm formation

OTHER

Biofilm formation after 12 and 36 h on PMMA (polymethyl methacrylate) dentures and the number of brushing cycles needed to remove it.

Other: 12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.

Interventions

12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it. OTHER

Capturing the clinical data for biofilm formation on PMMA dentures and samples worn by participants and the number of brushing cycles required to remove this biofilm. Development of artificial denture biofilm substitute with similar mechanical properties to real denture biofilm.

Biofilm formation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals 18 years of age or older
• Individuals wearing sufficient acrylic resin (PMMA) complete upper or complete upper and lower denture
• healthy oral mucosa
• written informed consent

You may not qualify if:

• Individuals who have severe systemic and/or infectious diseases
• Female individuals who are pregnant or breastfeeding
• allergies or hypersensitivity to the used products and/or materials
• smokers
• Individuals with a history of chronic drug abuse or another illness which does not allow the participant to assess the nature and/or possible consequences of the study
• inability to comply with study protocol requirements
• Individuals who have participated in another clinical study less than 4 weeks prior to the baseline examination

Sponsors & Collaborators

• Technische Universität Dresden: lead
• German Research Foundation: collaborator

Study Sites (1)

Department of Prosthetic Dentistry, Carl Gustav Carus Faculty of Medicine, TU Dresden

Dresden, Saxony, 01307, Germany

Location

Related Publications (7)

• Bowen WH, Burne RA, Wu H, Koo H. Oral Biofilms: Pathogens, Matrix, and Polymicrobial Interactions in Microenvironments. Trends Microbiol. 2018 Mar;26(3):229-242. doi: 10.1016/j.tim.2017.09.008. Epub 2017 Oct 30.

  PMID: 29097091 BACKGROUND

• Flemming HC, Wingender J. The biofilm matrix. Nat Rev Microbiol. 2010 Sep;8(9):623-33. doi: 10.1038/nrmicro2415. Epub 2010 Aug 2.

  PMID: 20676145 BACKGROUND

• Nikawa H, Hamada T, Yamamoto T. Denture plaque--past and recent concerns. J Dent. 1998 May;26(4):299-304. doi: 10.1016/s0300-5712(97)00026-2.

  PMID: 9611934 BACKGROUND

• Coulthwaite L, Verran J. Potential pathogenic aspects of denture plaque. Br J Biomed Sci. 2007;64(4):180-9. doi: 10.1080/09674845.2007.11732784.

  PMID: 18236742 BACKGROUND

• Russell SL, Boylan RJ, Kaslick RS, Scannapieco FA, Katz RV. Respiratory pathogen colonization of the dental plaque of institutionalized elders. Spec Care Dentist. 1999 May-Jun;19(3):128-34. doi: 10.1111/j.1754-4505.1999.tb01413.x.

  PMID: 10860077 BACKGROUND

• El-Solh AA, Pietrantoni C, Bhat A, Okada M, Zambon J, Aquilina A, Berbary E. Colonization of dental plaques: a reservoir of respiratory pathogens for hospital-acquired pneumonia in institutionalized elders. Chest. 2004 Nov;126(5):1575-82. doi: 10.1378/chest.126.5.1575.

  PMID: 15539730 BACKGROUND

• Hoad-Reddick G, Grant AA, Griffiths CS. Investigation into the cleanliness of dentures in an elderly population. J Prosthet Dent. 1990 Jul;64(1):48-52. doi: 10.1016/0022-3913(90)90152-3.

  PMID: 2384898 BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Interventions

Dentures

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Officials

• Katarzyna Walczak, Dr.med.dent.

  Department of Prosthetik Dentistry, Faculty of Medicine, TU Dresden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group, prospective, longitudinal, interventional pilot study to test the feasibility of study design, protocol, and methods for evaluating the artificial dentures biofilm equivalent. This pilot study is intended to provide initial data and insights into the development and establishment of an artificial dentures biofilm equivalent. According to the current state of research, no data, therefore, are available.

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 30, 2020
• Study Start: March 2, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)